Teva Pharmaceuticals USA recalls Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intrave…

Recall date

April 28, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1089-2015

FDA classification

Class I

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Nationwide

Why it was recalled

Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11